Noninvasive VentilationNCT07298889
High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS
A study testing The level of PEEP during noninvasive ventilation in people with Noninvasive Ventilation and Pneumonia, run by Chongqing Medical University at 1 site in China.
Trial summary
Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, Pneumonia, ARDS
- What is being tested?
- The level of PEEP during noninvasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315（SpO2 ≤97%)
- Anticipated NIV duration > 12 h
- Preserved consciousness (GCS≥13)
Who cannot join
- Use of NIV > 24 h before randomization
- Acute-on-chronic respiratory failure
- Congestive heart failure
- Use of NIV after extubation (within 48 hours)
- Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery [within 7 days])
- Pneumothorax
Show all 10Show fewer
- NIV intolerance
- Refusal to participate
- Pregnancy
- Need for emergency intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Jun Duan, 86-023-89012680, duanjun412589@163.com
About this study
Official title: Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial
Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.
- Conditions
- Noninvasive Ventilation, Pneumonia, ARDS
- Being tested
- The level of PEEP during noninvasive ventilation
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The level of PEEP during noninvasive ventilationProcedure or surgery
In patients receiving noninvasive ventilation, participants will be randomly assigned to either a low or a high PEEP group. In the high PEEP group, PEEP will be set between 10 and 15 cmH2O. In the low PEEP group, PEEP will be maintained at 5 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| High PEEP group | Experimental | Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation. Receives: Procedure: The level of PEEP during noninvasive ventilation |
| Low PEEP group | Active comparator | Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation. Receives: Procedure: The level of PEEP during noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day intubation-free survival
Measured: from randomization to 28 days after randomization
Secondary outcomes (11)
28-day intubation rate
Measured: from randomization to 28 days after randomization
the need for intubation within 28 days
The rate of the need for intubation within 28 days after randomization was assessed by two independent reviewers with extensive critical care experience.
Measured: from randomization to 28 days after randomization
28-day survival
Measured: from randomization to 28 days after randomization
7-category ordinal scale for clinical improvement at 28 days
The 7-category ordinal scale is as follows: 1 = not hospitalized and has resumed normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized without requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring HFNC, NIV, or both; 6 = hospitalized and requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; 7 = death.
Measured: from randomization to 28 days after randomization
28-day invasive ventilator-free days
Measured: from randomization to 28 days after randomization
28-day noninvasive ventilator days
Measured: from randomization to 28 days after randomization
Length of ICU stay
Measured: up to 24 weeks
Length of hospital stay
Measured: up to 24 weeks
ICU mortality
Measured: up to 24 weeks
Hospital mortality
Measured: up to 24 weeks
60-day mortality
Measured: from randomization to 60 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start4 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duan jun, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298889
- Sponsor's protocol ID
- ChongqingMU06
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: These study data contain ethnic demographic information. Since it remains unclear whether Chinese laws permit the public disclosure of such data upon the completion of the research, a decision has been made to temporarily withhold data sharing during the study design phase.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07298889
- Acronym / sponsor ID
- ChongqingMU06
- Conditions
- Noninvasive Ventilation, Pneumonia, ARDS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 706 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High PEEP group | Experimental | Procedure: The level of PEEP during noninvasive ventilationPatients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation. |
| Low PEEP group | Active comparator | Procedure: The level of PEEP during noninvasive ventilationPatients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315（SpO2 ≤97%)
- Anticipated NIV duration > 12 h
- Preserved consciousness (GCS≥13)
Key exclusion criteria (10 listed)
- Use of NIV > 24 h before randomization
- Acute-on-chronic respiratory failure
- Congestive heart failure
- Use of NIV after extubation (within 48 hours)
- Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery [within 7 days])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The level of PEEP during noninvasive ventilationIn patients receiving noninvasive ventilation, participants will be randomly assigned to either a low or a high PEEP group. In the high PEEP group, PEEP will be set between 10 and 15 cmH2O. In the low PEEP group, PEEP will be maintained at 5 cmH2O. | Procedure or surgery | High PEEP group, Low PEEP group |
Primary outcome
28-day intubation-free survival
Time frame: from randomization to 28 days after randomization
11 secondary outcomes
28-day intubation rate
Time frame: from randomization to 28 days after randomization
the need for intubation within 28 days
Time frame: from randomization to 28 days after randomization
28-day survival
Time frame: from randomization to 28 days after randomization
7-category ordinal scale for clinical improvement at 28 days
Time frame: from randomization to 28 days after randomization
28-day invasive ventilator-free days
Time frame: from randomization to 28 days after randomization
28-day noninvasive ventilator days
Time frame: from randomization to 28 days after randomization
Length of ICU stay
Time frame: up to 24 weeks
Length of hospital stay
Time frame: up to 24 weeks
ICU mortality
Time frame: up to 24 weeks
Hospital mortality
Time frame: up to 24 weeks
60-day mortality
Time frame: from randomization to 60 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. These study data contain ethnic demographic information. Since it remains unclear whether Chinese laws permit the public disclosure of such data upon the completion of the research, a decision has been made to temporarily withhold data sharing during the study design phase.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The level of PEEP during noninvasive ventilation in people with Noninvasive Ventilation and Pneumonia, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengyi Ma (86-023-89012680, 1062914316@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day intubation-free survival (time frame: from randomization to 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.